The LC Bead Trial; Transarterial Chemoembolization of Hepatocellular Carcinoma (HCC)With a Drug-eluting Bead

The Washington University

Status

Terminated

Conditions

Hepatocellular Carcinoma

Treatments

Device: transarterial chemoembolization using a drug-eluting bead

Study type

Interventional

Funder types

Other

Identifiers

NCT01259024

201108256

Details and patient eligibility

About

This study involves the combined use of the FDA approved device, LC Bead and the FDA approved drug, Doxorubicin for the treatment of primary hepatocellular carcinoma (HCC). The current indication of the LC Bead is for the embolization of hypervascular tumors and arteriovenous malformations. The study is designed to establish if drug eluting beads are more effective and less toxic than standard chemoembolization treatment.

Full description

Patients will be given IV fluids and premedication with 500 mg metronidazole, 10 mg dexamethasone, and 8 mg ondansetron to prevent infection, limit pain and nausea. The femoral artery will be accessed and a catheter advanced into the superior mesenteric artery. Positioning of all catheters will be confirmed by injection of radiographic contrast material. Superior mesenteric angiography will be performed with images obtained through the portal venous phase to confirm patency and flow direction of the portal vein and determine the presence of aberrant supply to the right lobe of the liver by the superior mesenteric artery. The catheter will then be advanced into the celiac artery. Celiac angiography will be performed to determine remainder of the hepatic arterial anatomy. Selection of the tumor bearing artery will then be performed with a microcatheter which is advanced through the catheter in the celiac artery origin. Selection will be guided by fluoroscopy and will be at the lobar level or peripherally in all cases. Once the feeding vessel has been selected and confirmed by contrast injection, the physician will initiate embolization with LC Beads. Up to two vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared. The LC Beads will be mixed with radiographic contrast to ensure fluoroscopic visibility during injection. Under careful fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery reaches stasis prior to administration of both vials, the residual volume of LC Beads will be noted on the surgical report form. If after administration of the DEB, there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization. After confirming that the artery is appropriately treated, all catheters and guidewires will be removed from the femoral artery and hemostasis obtained.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age > 18
Patent main portal vein with hepatopetal flow
Bilirubin less than or equal to 2.5 mg/dl, albumin >2.8g/dl, alkaline phosphatase <630IU/L, AST <235IU/L, ALT <265IU/L, INR <2.0, PTT <40sec., absolute neutrophil count >1K/cumm, platelet count >100K/cumm
No encephalopathy
No previous biliary ductal intervention
Child A status
Confirmation of Hepatocellular Carcinoma (through biopsy or radiological exam)
Unresectable HCC and ineligible for possible curative therapies
Normal ECG with QT <480 msec within the previous 2 months
Normal MUGA scan within the previous 2 months
Measureable disease per the Response Evaluation Criteria in Solid Tumors (RECIST)
Subject is competent and willing to provide written informed consent in order to participate in the study

Exclusion criteria

Thrombosis or hepatofugal flow in the main portal vein; presence of a large shunt which in the operator's opinion precludes embolization
Replacement of greater than 50% of the liver parenchyma by tumor
Bilirubin greater than or equal to 2.6 mg/dl
ECOG performance status of 2 or greater
Previous liver directed therapy
Previous biliary intervention (excluding cholecystectomy)
Allergy to iodinated contrast used for angiography
Elevated creatinine greater than or equal to 1.8 mg/dl
Women who are pregnant or nursing
Patients in which any of the following are contraindicated: 1)the use of doxorubicin, 2)MRI or CT scans, 3) Hepatic embolization procedures
Patients with active bacterial or fungal infection that is deemed to be clinically significant by the investigator
Patients with cardiac disease, including congestive heart failure, recent myocardial infarction, or uncontrolled arrhythmias
Non-English speaking patients